DE29820434U1 - Bone fracture fixation system - Google Patents

Description

RICHTER, WERDERMANN &"&Ogr;&Mgr;:&Bgr;&agr;&Igr;)&Igr;-.£&tgr;^#··::":

EUROPEAN PATENT ATTORNEYS ■ PATENT ATTORNEYS
EUROPEAN TRADEMARK ATTORNEYS

HAMBURG ■ BERLIN

DIPL.-ING. JOACHIM RICHTER ■ BERLIN DIFL.-ING. HANNES GERBAULET ■ HAMBURG DIPL.-ING. FRANZ WERDERMANN · - 1986

NEW WALL IO KURFÜRSTENDAMM 218

2&Ogr;354 HAMBURG &Igr;&Ogr;719 BERLIN

@ (O4O) 34 OO 45/34 OO 56 ® (O3O) 8 82 74 31 FAX (O4O) 35 24 15 FAX (O3O) 8 82 32

IN OFFICE COMMUNITY WITH

MAINITZ & MAINITZ

LAWYERS - NOTARIES

YOUR SIGN YOUR FILE

OUR SIGN OUR FILE

H 98482 III 2569

HAMBURG 11.11.1998

Applicant:

DUNSCH-HERZBERG, Renate
Holmer Strasse 165
D-22880 Wedel (DE)

VOSS, Gudrun

Cranz 26

D-25491 Hetlingen (DE)

Title:

System for fixing bone fractures

Description

The invention relates to a system for fixing bone fractures, in particular unstable distal radius fractures, in a predetermined repositioning position, which comprises at least one flexible tubular part made of plastic, which is positioned outside a patient opposite the

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Bone fragments can be arranged, wires, nails and/or screws fastened in the various bone fragments, which can be connected to the flexible tubular part, and a hardenable material which can be filled into the flexible tubular part in such a way that after the material has hardened, a solid frame is formed with the wires, nails and/or screws, which holds the bone fragments together for growing together in the predetermined repositioning position, according to the preamble of claim 1.

EP 0 260 484 B1 discloses a generic "external fixator" in which the two free ends of the tubular part are connected to one another via a Y-shaped or T-shaped connecting piece.

It is the object of the present invention to improve a system of the above-mentioned type in such a way that when filling the tubular part, a simple control option is available regarding the progress of the filling of the flexible tubular part and the inclusion of larger air bubbles in the middle area of the tubular part far away from the ends is effectively avoided when filling the flexible tubular part and without special precautions during filling, so that sufficient stability is guaranteed over the entire area of the flexible tubular part.

This object is achieved by a system of the above-mentioned type with the features characterized in claim 1.

For this purpose, the invention provides that a closure clamp is provided at a first end of the flexible tubular part, which closes the first end and is a receiving part for a section of the flexible

tubular part which is designed such that it fixes the flexible tubular part in a section near a second end thereof, the second end remaining open and accessible.

This has the advantage that after simplified assembly of the system according to the invention, the second open end of the flexible tubular part ensures that it can be easily filled with the hardenable material. Furthermore, the free choice of the section adjacent to the second end, which is fixed in the locking clamp, results in greater flexibility and adaptability to a wide variety of repositioning tasks, as well as more universal applicability of the system according to the invention. Furthermore, there is the advantage that, by allowing the second open end to protrude beyond the locking clamp for a correspondingly long time, a feed point for the hardenable material is located far away from the surgical site, which is to be kept sterile, so that the corresponding feed means for the hardenable material do not have to be sterile themselves and can be operated or fed by a non-sterile assistant. By introducing the hardenable material from just one open end, the material is pressed through the entire flexible tubular part and pushes any air bubbles that may be present in front of it, so that they are only present in the area of the first end. It is also advisable to provide a venting device at the first end so that such air bubbles can escape from the flexible tubular part.

Preferably further developments of the device are described in claims 2 to 14.

To monitor the progress of filling the flexible tubular part with a hardenable material, the locking clamp

a viewing window which is arranged in such a way that it provides a visual view into the first closed end of the flexible tubular part.

In a preferred embodiment, the locking clamp is designed as a one-piece plastic injection-molded part.

For convenience, an appropriate number of hose connection clamps are provided for connecting the wires, nails and/or screws to the flexible tubular part.

Any desired connection of the flexible tubular part to the wires, nails and/or screws is achieved by the hose connection clamps comprising two elements connected to a hinge, for example a film hinge, each element having a part of a receptacle for the flexible tubular part and a receptacle for the wires, screws and/or nails, a locking mechanism being arranged on the elements, which locks the two elements together when they are pivoted together about the hinge in such a way that the flexible tubular part is firmly connected to the hose connection clamp. It is particularly advantageous here that any freely selectable sections of the flexible tubular part can be connected to the respective wires, nails and/or screws.

To form a solid frame, the hose connection clamps also have a press-fit device which, when pressed with a tool, forms an inseparable connection between the two elements of the hose connection clamps with the wire, nail or screw.

In a preferred embodiment, the compressible device has a clamping cone for each element of the hose connection clamp, each clamping cone being arranged in a through-opening of the corresponding element for a respective wire, nail or screw, and this through-opening having engagement means which, when the clamping cone is pressed into the through-opening, cooperate with corresponding engagement means on the clamping cone to form a firm and permanent connection of the elements with the respective wire, nail or screw.

In a preferred embodiment, the hose connection clamps are designed as a one-piece plastic injection-molded part. The hinge is expediently designed as a film hinge.

The hardenable material is a two-component material. To supply the hardenable material, a cartridge pump, which can be operated manually, is particularly advantageously provided, which has a cartridge with a discharge opening for the hardenable material. To shield the non-sterile pump from the sterile operating field, a sterile protective cap is provided, which can be pushed over the cartridge.

For dispensing two-component materials which harden after mixing, the cartridge has two chambers for the two components of the hardenable material, the discharge opening of the cartridge being connected to both chambers and a mixing tip being provided which can be detachably connected to the discharge opening by means of a fastening mechanism, which is in particular a bayonet lock, the two components being mixed in the mixing tip before being introduced into the flexible tubular part.

The invention is explained in more detail below with reference to the accompanying drawings. These show

Fig. 1 shows a preferred embodiment of a system according to the invention

in perspective view,

Fig. 2 a locking clamp in perspective view, Fig. 3 in another perspective view, Fig. 4

to 6 a hose connection clamp in different perspective

Views,

Fig. 7 the hose connection clamp of Fig. 6 in a sectional view,

Fig. 8 shows a clamping cone for a hose connection clamp according to Fig. 6 and 7 in a perspective view,

Fig. 9 a sterile protective cap in perspective view,

Fig. 10 a manually operated pump mechanism for a cartridge pump in side view and

Fig. 11A to 11C with successive handling steps A to M of the inventive system.

The preferred embodiment of a system 100 according to the invention for fixing a bone fracture 10 of a, for example,

human bone 12 during a healing process comprises a flexible tubular part 14 and wires 16, which are connected both to the bone 12 or its fragments and to the tube 14. Tube connection clamps 18, described in more detail below, are provided for connecting the wires 16 to the tube 14. A closure clamp 22, described in more detail below, is arranged at a first end 20 of the tube 14 and closes this first end 20. A receiving part 24 for a section of the tube 14 is arranged on this closure clamp 22 adjacent to a second end 26, the second end 26 of the tube 14 remaining open. The tube 14, together with the wires 16, forms a solid frame after the hardening of a material introduced into the tube 14, which fixes the bone fragments of the bone 12 during a healing process or during the re-growth of the bone fragments.

The preferred embodiment of a closure clamp 22 shown in Figs. 2 and 3 comprises a film hinge 28, a locking tab 30 arranged on the receiving part 24 and a locking element 32 for receiving the locking tab 30. The receiving part 24 can be pivoted about the film hinge 28 so that the locking tab 30 engages the locking element to form a permanent connection. In the area of the closed end 20, the closure clamp 22 has a viewing window 31 through which the end 20 of the hose 14 can be seen. In this way, it is possible to see when the hardenable material pressed into the open end 26 completely fills the hose 14 and reaches the closed end 20.

The hose connection clamp 18 shown in Fig. 3 to 7 is formed from two elements 34 and 36, which are connected to one another via a film hinge 38.

are connected. A locking tab 40 with locking teeth 42 is formed on the first element 34, while a locking element 44 for receiving the locking tab 40 with a corresponding locking lug 46 is formed on the second element 36, which, in conjunction with the locking teeth, forms a fixed, possibly non-detachable connection. One half of a hose receptacle 48 is formed in each element 34, 36. Furthermore, each element 34, 36 comprises a through-opening 50 for inserting a respective wire through which the respective hose connection clamp 18 is to be connected.

The firm connection of the locking tab 40 with the locking element 44 ensures that the hose 14 is held firmly in the elements when they are pivoted together. Elevations 52 formed in the hose holder 48 prevent the hose 14 from slipping axially in the hose holder 48. Clamping cones 54 are inserted into the through-openings 50, as shown in Fig. 4. These clamping cones 54 have a central through-opening 56 for inserting a respective wire 16. By pressing the clamping cones 54 into the through-openings 56, a firm connection is created between the inserted wire 16 and the hose connection clamp 18. For this purpose, the clamping cone 54, as shown in Fig. 8, comprises corresponding engagement means 58, which, when the clamping cone 54 is pressed into the through-opening 50, cooperate with corresponding engagement means in the through-opening 50 to form a firm and permanent connection of the elements 34, 36 with the respective wire 16.

Fig. 9 shows a sterile protective cover 60 for a cartridge of a cartridge pump, described in more detail later, for introducing the hardenable material into the second open end 26 of the hose 14. Since this second open end 26 is far away from the surgical area that is to be kept sterile, the cartridge pump itself does not have to be kept sterile. Instead, it is sufficient to

Providing the sterile protective cover 60 over a part of the pump facing the surgical field, which is the cartridge to be emptied by the pump. In addition, only a mixing tip attached to a discharge opening of the cartridge and protruding from the sterile protective cover and to be inserted into the open second end 26 needs to be kept sterile.

Fig. 10 shows an example of a manual pump mechanism 62 of a cartridge pump. This pump mechanism 62 comprises two manually compressible lever arms 64, at least one of which serves as a handle for holding the cartridge pump. A cartridge (not shown in Fig. 10) can be arranged on a headstock 66, from which a hardenable material is dispensed by alternately compressing and releasing the lever arms 64.

Further features and advantages of the system according to the invention will become apparent from the following description of the handling based on Figs. 11A to 11M.

The system according to the invention is used specifically for the treatment of unstable distal radius fractures. The tube 14 is, for example, a glass fiber-plastic composite with mechanical properties similar to steel, but is still X-ray transparent. With a weight of just 70g, for example, it is very comfortable to wear. At the same time, it can be easily installed in freely selectable spatial planes. If a chain fixator is also used, any reproducible fracture repositioning is possible. There are no wearing parts and no return logistics.

After anesthesia (plexus, intravenous regional or general anesthesia), the patient is placed in a supine position with the upper body slightly raised and the arm outstretched

The arm is supported in the crook of the elbow with a roller and the
Fingers 1, 2 and 3 are extended using a scissor with a total of 3 kg of tension. A head-facing image converter position is advantageous. The monitor is preferably on the opposite side. An assistant is not required. The greatest possible repositioning through extension can now be fixed in the manner described below using the system according to the invention.

At suitable locations on bone 12, proximal to the fracture,
dorsal radius side perpendicular to the shaft axis pins or wires 16 are placed (Fig. 11A). After drilling with e.g. 1.5 mm through a drill guide sleeve
Pin 16 is screwed in manually and a second pin 16 is placed proximal to it using a distance drill guide. The position of pin 16 is checked under X-ray control.

After setting all other pins 16, the open hose connection clamps
18 with the element 36 is placed on the pins 16 (Fig. 11B). The spiral tube 14 is placed in the receptacles 48 of the open tube connection clamps 18, whereby the first end 20 with the locking clamp 22 is arranged approximately 4 cm from the proximal pin 16. The tube 14 expediently has
a length reserve to enable repositioning. The
Hose connection clamps 18 are closed.

When using a chain fixator, it is mounted in a relaxed manner from the outside under the glass fiber/spiral tube 14 onto the pins 16. Once the desired fracture reduction has been achieved, the chain fixator is tightened. This achieves a temporary rigid position.

Using a tool 68, the respective clamping cones 54 are pressed in and connect the respective pin 16 with the hose connection clamp 18

(Fig. 11C and 11D). Depending on the required hose length, the hose 14 is then placed into the locking clamp 22 with a section adjacent to the second open end 26 and the clamp is closed (Fig. 11E).

As shown in Fig. 11F, a non-sterile surgical assistant carefully places a non-sterile resin cartridge 70 into the cartridge pump 72 and removes a cap from the discharge opening 76 of the cartridge 70. The cartridge pump must be held at an angle upwards.

The sterile instrument operator then places the sterile cartridge protection cap 60 on the cartridge, as shown in Fig. 11G, and locks it with a cap 78 on the cartridge pump 72.

A sterile mixing tip 80 is screwed into the resin cartridge 70 as shown in Fig. 11H and then pushed completely into the second open end 26 of the tube 14. A rubber seal 82 prevents the resin mixture from running back during pumping. A free hand 84 of the operator secures the connection between the mixing tip 80 and the spiral tube 14.

The mixture is pressed into the hose 14 by means of smooth pumping movements, as indicated in Fig. 111 and 11k. After the pump handle 86 has been pulled through, it is briefly held in the tightened position to ensure even pressure equalization. When the hardenable material in the form of a resin mixture of two components reaches the viewing window 31 at the hose end 20, the pumping process is stopped and the pump handle 86 with cartridge 70 is put down or fixed using a cloth clamp. The resin cartridge 70 cannot be removed from the hose 14 at this stage. With a hardening time of, for example, 5 to 10 minutes, as indicated in Fig. 11L, 4 to 8 minutes remain after a pumping time of 1 to 2 minutes to

Curing and repositioning. The curing time depends on the temperature. The resin mixture hardens when heated and reaches around 90% of its strength in the first 5 to 10 minutes. Complete curing occurs within the next 12 hours.

The protruding end of the hose adjacent to the second open end 26 is now cut off with a hose cutter 88. A plunger of the cartridge pump 72 is pulled back, the empty resin cartridge 70 is removed and disposed of with the hospital waste without any special precautions.

LIST OF REFERENCE SYMBOLS

100 system 10 Bone fracture 12 Bone 14 flexible tubular part 16 Wires 18 Hose connection clamps 20 first end 22 Locking clamp 24 Receptacle for a section of the hose 26 second end 28 Film hinge 30 Locking tab 31 Viewing window 32 Locking element 34 first element 36 second element 38 Film hinge 40 Locking tab 42 Ratchet teeth 44 Locking element 46 locking lug 48 Hose holder 50 Passage opening 52 Surveys 54 Clamping cone 56 Through opening of the clamping cone 58 Intervention means

60 sterile protective cover 62 Pump mechanism 64 Lever arms 66 Head area 68 Tool 70 non-sterile resin cartridge 72 Cartridge pump 74 Closure 76 Discharge opening 78 Throw 80 Mixing tip 82 Rubber seal 84 free hand 86 Pump handle 88 Hose cutter

Claims (14)

Expectations 1. System (100) for fixing bone fractures (10), in particular
unstable distal radius fractures, in a predetermined repositioning position, which comprises at least one flexible tubular part (14) made of plastic, which is outside a patient
can be arranged opposite bone fragments to be fixed, wires (16), nails and/or screws fastened in the various bone fragments, which can be connected to the flexible tubular part (14), and a hardenable material which can be filled into the flexible tubular part (14) in such a way that after the material has hardened, a solid frame is formed with the wires (16), nails and/or screws, which holds the bone fragments together for growing together in the predetermined repositioning position, characterized, that at a first end (20) of the flexible tubular part (14) a closure clamp (22) is provided, which closes the first end (20) and has a receiving part (24) for a section of the flexible tubular part (14), which is designed such that it fixes the flexible tubular part (14) in a section near a second end (26) thereof, wherein the second end remains open (26) accessible. 2. System (100) according to claim 1,
characterized, that the closure clamp (22) has a viewing window (31) which is arranged in such a way that it ensures a visual insight into the first closed end (20) of the flexible tubular part (14). · · I 3. System (200) according to claim 1 or 2,
characterized, that the locking clamp (22) is designed as a one-piece plastic injection-molded part. 4. System (100) according to one of the preceding claims, characterized in that a corresponding number of hose connection clamps (18) are provided for connecting the wires (16), nails and/or screws to the flexible hose-shaped part (14). 5. System (100) according to claim 4,
characterized, that the hose connection clamps (18) comprise two elements (34, 36) connected by a hinge (38), each element (34, 36) having a part of a receptacle (48) for the flexible tubular part (14) and a receptacle (50) for the wires (16), screws and/or nails, a locking mechanism (40, 44) being arranged on the elements (34, 36), which locks the two elements (34, 36) together when they are pivoted together about the hinge (38) in such a way that the flexible tubular part (16) is firmly connected to the hose connection clamp. 6. System (100) according to claim 5,
characterized, that the hose connection clamps (18) further comprise a compressible device (54) which, when pressed with a tool (68), forms a permanent connection between the two elements of the hose connection clamps with the wire (16), nail or screw. 7. System (100) according to one of claims 5 or 6, characterized in that the compressible device has a clamping cone (54) for each element (34, 36) of the hose connection clamp (18), whereby each clamping cone (54) is arranged in a through-opening (50) of the corresponding element (34, 36) for a respective wire (16), nail or screw and this through-opening (50) has engagement means which, when the clamping cone (54) is pressed into the through-opening (50), cooperate with corresponding engagement means (58) on the clamping cone (54) to form a firm and permanent connection of the elements (34, 36) with the respective wire (16), nail or screw. 8. System (100) according to one of claims 5 to 7, characterized in that the hinge is designed as a film hinge (38). 9. System (100) according to one of claims 4 to 8, characterized in that the hose connection clamps (18) are designed as a one-piece plastic injection-molded part. 10. System (100) according to one of the preceding claims, characterized in that the hardenable material is a two-component material. 11. System (100) according to one of the preceding claims, characterized in that for supplying the hardenable material, a particularly A manually operated cartridge pump (72) is provided, which has a cartridge (70) with a discharge opening (76) for the hardenable material. 12. System (100) according to claim 11, characterized in that a sterile protective cap (60) is provided which can be pushed over the cartridge (70). 13. System (100) according to claim 11 or 12, characterized in that the cartridge (70) has two chambers for two components of a curable material, wherein the discharge opening (76) of the cartridge is connected to both chambers, and a mixing tip (80) is provided which can be detachably connected to the discharge opening (76) by means of a fastening mechanism, wherein in the mixing tip (80) a mixing of the two components takes place before introduction into the flexible tubular part (14). 14. System (100) according to claim 13, characterized in that the fastening mechanism is a bayonet lock.